Xytrex 10mg

Tablet
Olanzapine
ACI Pharmaceuticals

Other Strength:
- Xytrex 5mg

Alternative:
- Deprex 10mg



Xytrex
Description
Xytrex®is a preparationofOlanzapinewhich isan atypical antipsychoticagent. Olanzapine may work by blocking receptors for several neurotransmitters in the brain. Ithas a greater affinity for serotonin 5HT2 receptor and has lesser affinities fordopamine (D1, D2, D3, D4&D5); cholinergic muscarinic (M1-M5); adrenergic(α1);and histamine (H1)receptors.

Indication and usage
Xytrex®is indicated for the treatmentof schizophrenia; treatment of acute mixed or manic episodes with bipolar I disorder; in combination with lithium or valproate for short-term treatment of acute mixed or manic episodes associated with bipolar I disorder; maintenance treatment of bipolar patients on monotherapy after achieving a responder status for an average duration of 2 wk.

Dosage and administration
Adults
Schizophrenia:starting dose: 10 mgper day

Preventing recurrence in bipolar disorder:starting dose: 10 mg per day. For patients who have been receiving Xytrex®for treatment of manic episode, therapy should be continued for preventing recurrence at the same dose. Maintenance dose rangefor Schizophrenia, mania and preventing recurrence in bipolar

disorder:
5-20 per day.

Children and adolescents
Olanzapine is not recommended for children and adolescents below 18 years of age.

Elderly
A lower starting dose (5 mgper day) is not routinely indicated, but should be considered for those aged 65 years and above when clinical factors warrant.

Patients with renal and/or hepatic impairment
A lower starting dose (5 mg) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B), the starting dose should be 5 mg and should be increased with caution.

Use in pregnancy and lactation
Olanzapine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients taking Olanzapine should be advised not to breast-feed.

Precautions
Olanzapine may cause somnolence and dizziness, so patients should becautioned about operating machinery, including motor vehicles.Patients with clinically important prostatic hypertrophy, CV disease, conditions that predispose patients to hypotension (eg, dehydration, hypovolemia), narrow-angle glaucoma, a history of paralytic ileus, seizures should use Olanzapine with caution.

Side effects
Common: weight gain, dizziness, extrapyramidal symptoms (usually mild and transient), drowsiness, speech difficulty, exacerbation of Parkinson’s disease, abnormal gait, hallucinations, akathisia, asthenia, fatigue, increased appetite, eosinophilia; Less Common:bradycardia, QT interval prolongation, photosensitivity.Rare:seizures, leucopenia, rash; Very Rare:thromboembolism, hypercholesterolaemia, hypothermia, urinary retention, thrombocytopenia, neutropenia, rhabdomyolysis, hepatitis, pancreatitis and alopecia

Drug interactions
Drugs which inhibit or act as a substrate to Cytochrome P450isoenzymes orglucoronyl transferase enzymes (omeprazole, rifampicin, fluvoxamine), dopamine agonists, antiarrhythmics (methyl dopa, guanethidine, procainamide, quinidine), tricyclic antidepressants (fluvoxamine, fluoxetine), antiepileptics (phenobarbitone, carbamazepine, phenytoin), terfenadine.

Contraindications
Olanzapine is contra-indicated inpatientswith known hypersensitivity to the active substanceorto any of the excipientsandalso contra-indicated innarrow-angle glaucoma.

Overdose
Common symptoms include tachycardia, agitation/aggressiveness, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma. Other symptoms include delirium, convulsion, respiratory depression, aspiration, hypertension or hypotension, cardiac arrhythmias, and cardiopulmonary arrest.

Pharmaceutical precautions
Store in a cool and dry place. Protect from light.

Presentation
Xytrex®5 tablet: Each tablet contains OlanzapineINN 5 mg.
Xytrex®10 tablet: Each tablet contains Olanzapine INN 10 mg.

Packaging
Xytrex®5 tablet: Carton of 50 tablets in blister
Xytrex®10 tablet: Carton of 50tablets in blister


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